Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Refractory or Unexplained Chronic Cough

In brief

This is a phase 2b, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of Taplucainium Inhalation Powder (NOC-110) once daily in adults with refractory or unexplained chronic cough.

Key facts

Study ID

NCT06504446

Run by

Nocion Therapeutics

People needed

455

Starts

2024-09-24

Expected to finish

2026-06-29

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Refractory or unexplained chronic cough for ≥ 12 months.
• Women of childbearing potential agree to follow the protocol specified contraceptive - guidance during the study.
• Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol.
• Able to provide Informed Consent.

You may not qualify if…

• Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
• Participants who are currently participating in another drug or device clinical study
• Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening.
• Current diagnosis of chronic obstructive pulmonary disease, bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma, or other pulmonary disease.
• Respiratory tract infection within 4 weeks of Screening or during screening period.
• Any female who is pregnant or lactating or wishing to become pregnant.
• Donation of > 1 Unit (450 milliliter or more) of blood within 60 days prior to the first dosing.
• Alcohol or drug use disorder within the past 2 years.
• Current smoker/vaper or individuals who have given up smoking within the past 6 months of screening, and/or those with >20 pack-year smoking history.
• Current opiate/opioid use or medical history of opiate/opioid use disorder.
• History of concurrent malignancy or recurrence of malignancy in the last 2 years.
• Body Mass Index of ≥40 kg/m2.
• Positive results for human immunodeficiency virus, hepatitis B, or hepatitis C virus.
• Unable to refrain from the use of medications and treatments that can impact cough during the study.
• Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).

Where it is running

• Medical Research of Arizona — Scottsdale, Arizona, United States
• AMR Phoenix — Tempe, Arizona, United States
• Little Rock Allergy & Asthma, P.A. Clinical Research Center — Little Rock, Arkansas, United States
• So Cal Clinical Research — Huntington Beach, California, United States
• Allergy and Asthma Associates of Southern California dba Southern California Research — Laguna Niguel, California, United States
• Paradigm Clinical Research Centers, LLC - Modesto — Modesto, California, United States
• NewportNativeMD,Inc — Newport Beach, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Paradigm Clinical Research Centers, LLC — Redding, California, United States
• DaVinci Research LLC. — Roseville, California, United States
• Allergy & Asthma Associates of Santa Clara Valley — San Jose, California, United States
• California Allergy & Asthma Medical Group Inc. — San Jose, California, United States
• Allergy, Asthma, and Immunology Medical Group — Ventura, California, United States
• Allergy and Asthma Clinical Research Inc — Walnut Creek, California, United States
• Lynn Institute of Denver — Aurora, Colorado, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Omega Research Debary, LLC — DeBary, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Clinical Site Partners, LLC Leesburg dba Flourish Research — Leesburg, Florida, United States
• Suncoast Research Group, LLC Miami - Little Havana dba Flourish Research — Miami, Florida, United States
• Well Pharma Medical Research Corporation — Miami, Florida, United States
• University of South Florida - PARENT — Tampa, Florida, United States
• Clinical Site Partners, LLC Orlando dba Flourish Research — Winter Park, Florida, United States
• Aeroallergy Research Laboratories of Savannah, Inc. — Savannah, Georgia, United States
• G & L Research, LLC — Foley, Alabama, United States

Full record on ClinicalTrials.gov

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